FDA.reportPublic FDA data

WoundFLEX

Primary DI
00850744001760
Brand
WoundFLEX
Company
Lifescience Plus, Inc.
Model
WF-50
Catalog number
WF-50
Device description
"WoundFLEX Burn Assist, Flexible Compression Dressing, 6""x60"" (15cmX152cm)"
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MHWDressing, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850744001760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850744001760008507440017608507440017600850744001760

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, non-latex, single-useA strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area360Square inch

Regulatory Flags#

DUNS number
190600051
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850744001609BloodSTOP8322302024-07-10
00850744001364SealkSK-iX-342024-06-25
00850744001302SealkSK-iX-162024-06-25
10850744001361SealkSK-iX-342024-06-25
00850744001371SealkSK-iX-222024-06-25
00850744001401BloodSTOP iXBS-iX-232024-06-25
00850744001449BloodSTOP iX Trauma MatrixTM-iX-262024-06-25
00850744001104BloodSTOPBS-10BS-102022-12-08
00850744001111BloodSTOPBS-11BS-112022-12-08
00850744001128BloodSTOPBS-12BS-122022-12-08
00850744001135BloodSTOPBS-13BS-132022-12-08
00850744001180BloodSTOPBS-MP-18BS-MP-182022-12-08
00850744001241BloodSTOP iXBS-iX-14BS-iX-142022-12-08
00850744001258BloodSTOP iXBS-iX-15BS-iX-152022-12-08
00850744001265BloodSTOP iXBS-iX-17BS-iX-172022-12-08
00850744001272BloodSTOP iXBS-iX-20BS-iX-202022-12-08
00850744001289BloodSTOP iXBS-iX-27BS-iX-272022-12-08
00850744001296BloodSTOPBS-OTC-28BS-OTC-282022-12-08
00850744001098BloodSTOPBS-09BS-092022-12-08
00850744001142BloodSTOP iXBS-iX-14NBS-iX-14N2022-12-08

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M68931150030TQ™ RAMSafeguard US Operating, LLCMHW2025-01-29
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10193489084658MEDLINEMEDLINE INDUSTRIES, INC.MHW2024-09-13
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00840117327825"Sensi Wrap,Self-Adherent - Latex Free 2 x 5"" yds Green"Dynarex CorporationMHW2023-12-20
00840117327849"Sensi Wrap,Self-Adherent - Latex Free 2 x 5"" yds Light Blue"Dynarex CorporationMHW2023-12-20
00840117327863"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yds Purple "Dynarex CorporationMHW2023-12-20
00840117327887"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yd Pink"Dynarex CorporationMHW2023-12-20
00840117327900"Sensi Wrap,Self-Adherent - Latex Free 3"" x 5 yds Red"Dynarex CorporationMHW2023-12-20
00840117327924"Sensi Wrap,Self-Adherent - Latex Free 3"" x 5 yds Green"Dynarex CorporationMHW2023-12-20
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00840117327740"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Blue"Dynarex CorporationMHW2023-12-17
00840117327764"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Purple "Dynarex CorporationMHW2023-12-17
00840117327788"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Pink"Dynarex CorporationMHW2023-12-17
00840117327801"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yd Red "Dynarex CorporationMHW2023-12-17
10811331010173Comfort BandTz Medical, Inc.MHW2023-10-20
10811331010180Comfort BandTz Medical, Inc.MHW2023-10-20
00810113571249ViveVIVE HEALTH LLCMHW2023-08-07
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00810113571959ViveVIVE HEALTH LLCMHW2023-08-07
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00810113571973ViveVIVE HEALTH LLCMHW2023-08-07